Feature

The ABC of CRA's

Summary

The role of Clinical Research Associate (CRA) is a vital one in the pharmaceutical industry and as such commands both significant responsibility and impressive remuneration. A Clinical Research Associ

The role of Clinical Research Associate (CRA) is a vital one in the pharmaceutical industry and as such commands both significant responsibility and impressive remuneration. A Clinical Research Associate’s principle role is in monitoring the progress of a Clinical Trial either from an overall standpoint, or focused on an individual area of the trial such as initiation, ensuring the scientific integrity of the data collected or monitoring the well-being of the trial patients. A well-trained and knowledgeable CRA plays a vital role in helping to reduce the time between drug discovery and marketing approval, whilst ensuring that drugs for humans are safe. While the demand for experienced CRAs continues to grow, it can be difficult to get that first foot on the ladder that can lead to a career as a CRA.

The qualifications needed to become a CRA are similar to those needed for a Medical Sales Rep. Sophie Gardiner, Contract Personnel Manager with Chiltern International says “Firstly, it is important to have a degree in a life sciences discipline or a nursing background. It is phenomenally difficult to secure a Junior CRA (JCRA) position otherwise.“ From this point you need to be working towards a Junior CRA position, a process that will usually take between 12 and 18 months. As part of this process it is essential that you become familiar with the terminology associated with clinical trials work. Keep an eye on the Institute of Clinical Research website www.acrpi.com and publications like Clinical Research Focus (CRF). Also look regularly at the websites of the leading CRO’s (see links to their sites by clicking here and then clicking on the Clinical Research tab.

If you can develop this kind of knowledge and feel comfortable talking about Clinical Trials then you are on your way. The next step to becoming a JCRA is either to get on a company-run training course or alternatively get experience in a related role. The demand for good CRAs and the increased outsourcing of the role by the ethical pharmaceutical manufacturers has prompted many of the better CRO’s to run JCRA training programmes. Sophie Gardiner say, “Chiltern, for example, has an intake of JCRAs twice a year who are trained through a programme of lectures, workshops, and mentoring by senior clinical staff to enable them to become a CRA after six months”. If you aren’t lucky enough to land one of these coveted Roles like Clinical Trials Administrator, Clinical Project Assistant, Clinical Trials Co-ordinator or Data Manager will give you practical exposure to what A CRA’s job entails and also enable you to network effectively within the company that employs you. If you can’t get into a position like this, work that exposes you to the medical profession is also useful as CRAs spend the majority of their time in the company of doctors. With this kind of experience under your belt, your CV will move towards the top of the pile that inundates recruiters and employers for each JCRA role.

But are you as an individual cut out to be a good CRA, or will all this hard work go to waste? The typical CRA will be very well motivated and able to organise their time independently. CRAs spend a lot of their time on the road, working away from an office and so need to be able to operate efficiently without direct supervision. A CRA will be confident in dealing with a variety of people, from patients to world leading physicians and should be able to motivate and organise others well in order to get the information and statistics the company needs as quickly as possible. The precision demanded by the drug administration authorities worldwide demands that a good CRA will be meticulous in their administrative duties, problems with the clinical trials data submitted for drug approval can set back approval of a new drug by months or even years, costing the company millions. Aside from these traits all the other characteristics associated with being a good employee, reliability, punctuality, ability to get on with others etc. are standard for this kind of role. All of these facets of your personality must come across during the application process to ensure you do yourself justice. Sophie Gardiner says, “In any JCRA interview you will need to know the role and responsibilities of a CRA and the basics of ICH GCP and to rise above the rest, an outgoing, flexible and professional attitude is a must! A CRA role relies heavily on excellent verbal and written communication with many different professionals and personalities!”

So if you want to be a CRA your studying mustn’t end when you walk out of the examination hall. Become familiar with the terminology and language of clinical trials to give yourself a head start in landing one of the associated positions. From here do as good a job as you possibly can and try to develop a network of contacts to prepare your way to applying for a JCRA position. If you want further information the Institute of Clinical Research has an excellent publication entitled ‘To be a CRA’, available from their website at www.acrpi.com, many newcomers also join the Institute as an Associate Member. The Institute’s excellent Annual Spring Meeting takes place on March 25-26th this year in Birmingham, for more details click on the banner on the banner in the Clinical section of the site.

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